LAP-iX Suction Irrigation
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identity
- Trade Name
- LAP-iX EUDAMED
- Device Name
- PISTOL TYPE-1 L-HOOK EUDAMEDPISTOL TYPE-1 SPOON EUDAMEDPISTOL TYPE-2 SPOON EUDAMED
- Model / Reference
- SI-TLSL-02 EUDAMEDSI-PL-01 EUDAMEDSI-PL-03-01 EUDAMEDSI-TL-01 EUDAMEDSI-ED-02-01 EUDAMEDSI-ED-01-02 EUDAMEDSI-PL-03-02 EUDAMEDSI-PU-01 EUDAMEDSI-TU-01 EUDAMEDSI-ED-02-02 EUDAMEDSI-ED-01-01 EUDAMEDSI-TL-02-02 EUDAMEDSI-TLSL-01-01 EUDAMEDSI-TLSL-01 EUDAMEDSI-TL-03-01 EUDAMEDSI-TL-01-01 EUDAMEDSI-TLSL-02-02 EUDAMEDSI-PL-02-01 EUDAMEDSI-PU-02 EUDAMEDSI-ED-03-02 EUDAMEDSI-TL-02-01 EUDAMEDSI-TJSL-02 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08806182204005 EUDAMED08806182203466 EUDAMED08806182203626 EUDAMED08806182203664 EUDAMED08806182202193 EUDAMED08806182204104 EUDAMED08806182203640 EUDAMED08806182203503 EUDAMED08806182203701 EUDAMED08806182204128 EUDAMED08806182202179 EUDAMED08806182203923 EUDAMED08806182203985 EUDAMED08806182203787 EUDAMED08806182203947 EUDAMED08806182201950 EUDAMED08806182204043 EUDAMED08806182201936 EUDAMED08806182203527 EUDAMED08806182204166 EUDAMED08806182201974 EUDAMED08806182203886 EUDAMED
- Basic UDI-DI
- B-08806182204005 EUDAMEDB-08806182203466 EUDAMEDB-08806182203626 EUDAMEDB-08806182203664 EUDAMEDB-08806182202193 EUDAMEDB-08806182204104 EUDAMEDB-08806182203640 EUDAMEDB-08806182203503 EUDAMEDB-08806182203701 EUDAMEDB-08806182204128 EUDAMEDB-08806182202179 EUDAMEDB-08806182203923 EUDAMEDB-08806182203985 EUDAMEDB-08806182203787 EUDAMEDB-08806182203947 EUDAMEDB-08806182201950 EUDAMEDB-08806182204043 EUDAMEDB-08806182201936 EUDAMEDB-08806182203527 EUDAMEDB-08806182204166 EUDAMEDB-08806182201974 EUDAMEDB-08806182203886 EUDAMED
- 510(k) Number
- K200638 FDA 510(k)
- FDA Product Code
- HET FDA 510(k)
- EMDN Code
- K0201010302 LAPAR AND THORACOSCOPIC ELECTROSURGERY ELECTRODES, SINGLE-USE EUDAMED
Classification
- Device Class
- Class IIb EUDAMEDClass IIa EUDAMEDClass II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 884.1720 FDA 510(k)
- Regulation Number
- 884.1720 FDA 510(k)
- Market of Registration
- Greece EUDAMED
- Advisory Committee
- Obstetrics/Gynecology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Clinical & Handling
Sterile
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
The LAP-iX Suction Irrigation is a laparoscopic and endoscopic suction/irrigation device (product code HET) designed to facilitate fluid management during surgical procedures. It combines suction and irrigation capabilities while also enabling the delivery of high-frequency monopolar electrosurgical energy from compatible generators to the surgical site.
This device is intended for use in laparoscopic and endoscopic procedures within the Obstetrics/Gynecology specialty. Supplied as a reusable medical instrument, it requires appropriate sterilization before each use. The device has received FDA 510(k) clearance under the Special 510(k) pathway and complies with the Medical Device Directive (MDD). No specific MRI safety or single-use designation is noted in the available data.
Frequently asked questions
What surgical specialties is the LAP-iX Suction Irrigation primarily intended for, and how does that relate to its design features?
The LAP-iX Suction Irrigation is specifically designed for use in laparoscopic and endoscopic procedures within Obstetrics/Gynecology, as indicated by its regulatory filing. Its dual-functionality—combining suction, irrigation, and electrosurgical energy delivery—is particularly useful in this specialty for managing fluids and facilitating precise tissue manipulation during minimally invasive surgeries like hysterectomies or ovarian cyst removals.
Is the LAP-iX Suction Irrigation intended for single-use or reusable applications, and what does that mean for its maintenance?
The LAP-iX Suction Irrigation is not single-use; it is classified as a reusable medical instrument. This means it must undergo appropriate sterilization before each use to ensure safety and prevent cross-contamination, as explicitly stated in the device description.
What regulatory pathways has the LAP-iX Suction Irrigation followed, and what does that imply about its compliance standards?
The device has received FDA 510(k) clearance under the Special 510(k) pathway and complies with the Medical Device Directive (MDD). This implies it meets U.S. and EU regulatory requirements for safety and performance, though compliance specifics (e.g., ISO standards) are not detailed in the provided data. The Special 510(k) designation suggests it was deemed *substantially equivalent* to a predicate device.
Does the LAP-iX Suction Irrigation have any limitations regarding MRI compatibility or special handling requirements?
The available data does not specify MRI safety for the LAP-iX Suction Irrigation, meaning its compatibility with MRI environments (e.g., ferromagnetic properties or radiofrequency interference) is not confirmed or addressed. Clinicians should verify compatibility with their MRI systems before use, as metallic components could pose risks in magnetic fields. No single-use designation is noted, so reuse protocols apply.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: K200638 - LAP-iX Suction Irrigation | FDA 510 (k), PDF Sejong Medical Co., Ltd. -iX a - Food and Drug Administration, LAP-iX Suction Irrigation (K200638) — FDA 510(k) | Innolitics, LAP-iX Suction Irrigation 510 (k) K200638 - FDA.report
Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K200638 | Class II | Active |
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Manufacturer
- Manufacturer
- Sejong Medical Co., Ltd
- FDA Applicant
- Sejong Medical Co., Ltd.
Sources (23)
- FDA 510(k) K200638 24 fields · synced Sep 18, 2026
- EUDAMED c9f72695-6fab-405d-8765-92aab2767bea 61 fields · synced Jul 8, 2026
- EUDAMED 064a2076-e956-4e7c-9722-94dfc3776102 61 fields · synced Jul 9, 2026
- EUDAMED 12a253c0-0bfc-4ea0-a6a0-68606802bf03 61 fields · synced Jul 9, 2026
- EUDAMED e9a6dcf5-b205-462d-a491-e51c721aea52 61 fields · synced Jul 9, 2026
- EUDAMED 3f899db6-466a-44fc-b4fe-3ab03b409e98 61 fields · synced Jul 10, 2026
- EUDAMED 0e1eb785-9107-4952-bae5-c0e672618c4e 61 fields · synced Jul 11, 2026
- EUDAMED 9880e247-7087-4250-b86c-ea1a58a39544 61 fields · synced Jul 12, 2026
- EUDAMED 59e1dca3-c1ac-45a7-9c59-1a99e5a17022 61 fields · synced Jul 14, 2026
- EUDAMED c4b93c1f-4588-4f31-b3db-33b75f25a60c 61 fields · synced Jul 16, 2026
- EUDAMED 974ddfbd-faef-468b-9fe6-e863f59ba6f6 61 fields · synced Jul 17, 2026
- EUDAMED 97d2c980-f5d6-45e2-9838-187b7270d71b 61 fields · synced Jul 17, 2026
- EUDAMED 08a4e8e0-52f4-4c52-944f-a392f03b39a8 61 fields · synced Jul 19, 2026
- EUDAMED 3d23b2a9-3603-49d1-9086-01069f9749f1 61 fields · synced Jul 20, 2026
- EUDAMED df1da422-13f7-43e1-9cf5-521cd21b74c1 61 fields · synced Jul 20, 2026
- EUDAMED d83779fa-4397-4ec2-a937-3688ad25d8a9 61 fields · synced Jul 21, 2026
- EUDAMED 4e29edc1-b38d-4c32-ae25-36587fa77766 61 fields · synced Jul 23, 2026
- EUDAMED 2525119f-e428-4a47-8a64-6908a0369079 61 fields · synced Jul 28, 2026
- EUDAMED f13e115c-5762-4a79-bb21-d40950097202 61 fields · synced Jul 28, 2026
- EUDAMED 9786989a-1e05-46dc-82cb-a3e16f0aaac7 61 fields · synced Jul 30, 2026
- EUDAMED 88a6daa8-5dce-4850-9c1d-9d16886d9c90 61 fields · synced Jul 30, 2026
- EUDAMED 734ac396-0f0d-42fc-8f41-1333158aabcf 61 fields · synced Jul 31, 2026
- EUDAMED bfef27c2-16b0-40d6-83e1-c8244abd42c2 61 fields · synced Sep 18, 2026